FDA UDI
In Commercial Distribution
🇺🇸 United States
Clint Pharmaceuticals
DI: 00351688071753
·
Model: ACL6SP45
·
CLINT PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clint Pharmaceuticals
- Primary DI
- 00351688071753
- Version / Model
- ACL6SP45
- Company Name
- CLINT PHARMACEUTICALS, INC.
- Labeler DUNS
- 609197785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-13
- Public Version
- 5
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- c9f20eca-70d3-4e07-9bdc-247d4c162a79
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34842 | Epidural anaesthesia set, non-medicated | A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30351688071754 | GS1 | CASE | 30 | In Commercial Distribution | |
| Primary | 00351688071753 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K965017 | 000 |